PMID- 26703678 OWN - NLM STAT- MEDLINE DCOM- 20160912 LR - 20181202 IS - 1660-4601 (Electronic) IS - 1661-7827 (Print) IS - 1660-4601 (Linking) VI - 13 IP - 1 DP - 2015 Dec 22 TI - Computer Optimization of Biodegradable Nanoparticles Fabricated by Dispersion Polymerization. PG - ijerph13010047 LID - 10.3390/ijerph13010047 [doi] LID - 47 AB - Quality by design (QbD) in the pharmaceutical industry involves designing and developing drug formulations and manufacturing processes which ensure predefined drug product specifications. QbD helps to understand how process and formulation variables affect product characteristics and subsequent optimization of these variables vis-a-vis final specifications. Statistical design of experiments (DoE) identifies important parameters in a pharmaceutical dosage form design followed by optimizing the parameters with respect to certain specifications. DoE establishes in mathematical form the relationships between critical process parameters together with critical material attributes and critical quality attributes. We focused on the fabrication of biodegradable nanoparticles by dispersion polymerization. Aided by a statistical software, d-optimal mixture design was used to vary the components (crosslinker, initiator, stabilizer, and macromonomers) to obtain twenty nanoparticle formulations (PLLA-based nanoparticles) and thirty formulations (poly-varepsilon-caprolactone-based nanoparticles). Scheffe polynomial models were generated to predict particle size (nm), zeta potential, and yield (%) as functions of the composition of the formulations. Simultaneous optimizations were carried out on the response variables. Solutions were returned from simultaneous optimization of the response variables for component combinations to (1) minimize nanoparticle size; (2) maximize the surface negative zeta potential; and (3) maximize percent yield to make the nanoparticle fabrication an economic proposition. FAU - Akala, Emmanuel O AU - Akala EO AD - Center for Drug Research and Development, Department of Pharmaceutical Sciences, College of Pharmacy, Howard University, 2300 4th Street NW, Washington, DC 20059, USA. eakala@howard.edu. FAU - Adesina, Simeon AU - Adesina S AD - Center for Drug Research and Development, Department of Pharmaceutical Sciences, College of Pharmacy, Howard University, 2300 4th Street NW, Washington, DC 20059, USA. simeon.adesina@howard.edu. FAU - Ogunwuyi, Oluwaseun AU - Ogunwuyi O AD - Center for Drug Research and Development, Department of Pharmaceutical Sciences, College of Pharmacy, Howard University, 2300 4th Street NW, Washington, DC 20059, USA. temytayoo@yahoo.com. LA - eng GR - 1SC1CA199810-01/CA/NCI NIH HHS/United States GR - C06 RR020608/RR/NCRR NIH HHS/United States GR - 5P30A1087714-02/PHS HHS/United States GR - 1 C06 RR 020608-01/RR/NCRR NIH HHS/United States GR - C06 RR014469/RR/NCRR NIH HHS/United States GR - 1 C06 RR 14469-01/RR/NCRR NIH HHS/United States GR - SC1 CA199810/CA/NCI NIH HHS/United States PT - Journal Article PT - Research Support, N.I.H., Extramural DEP - 20151222 PL - Switzerland TA - Int J Environ Res Public Health JT - International journal of environmental research and public health JID - 101238455 SB - IM MH - Chemistry, Pharmaceutical MH - *Computer-Aided Design MH - Drug Industry/*methods MH - Nanoparticles/*chemistry MH - Particle Size MH - *Polymerization MH - Technology, Pharmaceutical/*methods PMC - PMC4730438 OTO - NOTNLM OT - ">d-optimal mixture design OT - computer optimization OT - dispersion polymerization OT - nanoparticles OT - quality by design (QbD) OT - statistical design of experiments EDAT- 2015/12/26 06:00 MHDA- 2016/09/13 06:00 PMCR- 2016/01/01 CRDT- 2015/12/26 06:00 PHST- 2015/08/15 00:00 [received] PHST- 2015/11/04 00:00 [revised] PHST- 2015/11/12 00:00 [accepted] PHST- 2015/12/26 06:00 [entrez] PHST- 2015/12/26 06:00 [pubmed] PHST- 2016/09/13 06:00 [medline] PHST- 2016/01/01 00:00 [pmc-release] AID - ijerph13010047 [pii] AID - ijerph-13-00047 [pii] AID - 10.3390/ijerph13010047 [doi] PST - epublish SO - Int J Environ Res Public Health. 2015 Dec 22;13(1):ijerph13010047. doi: 10.3390/ijerph13010047.